Professional Documents
Culture Documents
American Diabetic Association 2011
American Diabetic Association 2011
S T A T E M E N T
CONTENTS
I. CLASSIFICATION AND DIAGNOSIS
OF DIABETES, p. S12
A. Classification of diabetes
B. Diagnosis of diabetes
C. Categories of increased risk for diabetes (prediabetes)
II. TESTING FOR DIABETES IN ASYMPTOMATIC PATIENTS, p. S13
A. Testing for type 2 diabetes and risk
of future diabetes in adults
B. Testing for type 2 diabetes in children
C. Screening for type 1 diabetes
III. DETECTION AND DIAGNOSIS OF
GESTATIONAL DIABETES MELLITUS, p. S15
IV. PREVENTION/DELAY OF TYPE 2
DIABETES, p. S16
V. DIABETES CARE, p. S16
A. Initial evaluation
B. Management
C. Glycemic control
1. Assessment of glycemic control
a. Glucose monitoring
b. A1C
2. Glycemic goals in adults
D. Pharmacologic and overall approaches to treatment
1. Therapy for type 1 diabetes
2. Therapy for type 2 diabetes
E. Diabetes self-management education
F. Medical nutrition therapy
G. Physical activity
H. Psychosocial assessment and care
I. When treatment goals are not met
J. Hypoglycemia
K. Intercurrent illness
L. Bariatric surgery
M. Immunization
VI. PREVENTION AND MANAGEMENT
OF DIABETES COMPLICATIONS, p.
S27
A. Cardiovascular disease
1. Hypertension/blood pressure
control
2. Dyslipidemia/lipid management
3. Antiplatelet agents
4. Smoking cessation
5. Coronary heart disease screening and treatment
B. Nephropathy screening and treatment
C. Retinopathy screening and treatment
D. Neuropathy screening and treatment
E. Foot care
VII. DIABETES CARE IN SPECIFIC POPULATIONS, p. S38
A. Children and adolescents
1. Type 1 diabetes
Glycemic control
a. Screening and management of
chronic complications in children and adolescents with
type 1 diabetes
i. Nephropathy
ii. Hypertension
iii. Dyslipidemia
iv. Retinopathy
v. Celiac disease
vi. Hypothyroidism
b. Self-management
c. School and day care
d. Transition from pediatric to
adult care
2. Type 2 diabetes
3. Monogenic diabetes syndromes
B. Preconception care
C. Older adults
D. Cystic fibrosisrelated diabetes
VIII. DIABETES CARE IN SPECIFIC
SETTINGS, p. S43
A. Diabetes care in the hospital
1. Glycemic targets in hospitalized
patients
2. Anti-hyperglycemic agents in
hospitalized patients
3. Preventing hypoglycemia
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S11
Description
Clear evidence from well-conducted, generalizable, randomized controlled
trials that are adequately powered, including:
Evidence from a well-conducted multicenter trial
Evidence from a meta-analysis that incorporated quality ratings in the
analysis
Compelling nonexperimental evidence, i.e., all or none rule developed
by Center for Evidence Based Medicine at Oxford
Supportive evidence from well-conducted randomized controlled trials
that are adequately powered, including:
Evidence from a well-conducted trial at one or more institutions
Evidence from a meta-analysis that incorporated quality ratings in the
analysis
Supportive evidence from well-conducted cohort studies
Evidence from a well-conducted prospective cohort study or registry
Evidence from a well-conducted meta-analysis of cohort studies
Supportive evidence from a well-conducted case-control study
Supportive evidence from poorly controlled or uncontrolled studies
Evidence from randomized clinical trials with one or more major or
three or more minor methodological flaws that could invalidate the
results
Evidence from observational studies with high potential for bias (such
as case series with comparison to historical controls)
Evidence from case series or case reports
Conflicting evidence with the weight of evidence supporting the
recommendation
Expert consensus or clinical experience
S12
lin action, diseases of the exocrine pancreas (such as cystic fibrosis), and drugor chemical-induced (such as in the
treatment of HIV/AIDS or after organ
transplantation)
Gestational diabetes mellitus (GDM)
(diabetes diagnosed during pregnancy
that is not clearly overt diabetes)
2-h value in the 75-g oral glucose tolerance test (OGTT) (4).
In 2009, an International Expert
Committee that included representatives
of the ADA, the International Diabetes
Federation (IDF), and the European Association for the Study of Diabetes
(EASD) recommended the use of the A1C
test to diagnose diabetes, with a threshold
of 6.5% (5), and ADA adopted this criterion in 2010 (4). The diagnostic test
should be performed using a method that
is certified by the National Glycohemoglobin Standardization Program (NGSP)
and standardized or traceable to the Diabetes Control and Complications Trial
(DCCT) reference assay. Point-of-care
A1C assays are not sufficiently accurate at
this time to use for diagnostic purposes.
Epidemiologic datasets show a similar relationship between A1C and risk of
retinopathy as has been shown for the
corresponding FPG and 2-h plasma glucose thresholds. The A1C has several advantages to the FPG and OGTT, including
greater convenience, since fasting is not
required; evidence to suggest greater preanalytical stability; and less day-to-day
perturbations during periods of stress and
illness. These advantages must be balanced by greater cost, the limited availability of A1C testing in certain regions of
the developing world, and the incomplete
correlation between A1C and average glucose in certain individuals. In addition,
A1C levels can vary with patients ethnicity (6) as well as with certain anemias and
hemoglobinopathies. For patients with an
abnormal hemoglobin but normal red cell
turnover, such as sickle cell trait, an A1C
assay without interference from abnormal
hemoglobins should be used (an updated
list is available at www.ngsp.org/interf.
asp). For conditions with abnormal red
cell turnover, such as pregnancy, recent
blood loss or transfusion, or some anemias, the diagnosis of diabetes must employ glucose criteria exclusively.
The established glucose criteria for
the diagnosis of diabetes (FPG and 2-h
PG) remain valid as well (Table 2). Just as
there is less than 100% concordance between the FPG and 2-h PG tests, there is
not perfect concordance between A1C
and either glucose-based test. Analyses of
National Health and Nutrition Examination Survey (NHANES) data indicate that,
assuming universal screening of the undiagnosed, the A1C cut point of 6.5%
identifies one-third fewer cases of undiagnosed diabetes than a fasting glucose cut
point of 126 mg/dl (7.0 mmol/l) (7).
care.diabetesjournals.org
Position Statement
Table 2Criteria for the diagnosis of
diabetes
A1C 6.5%. The test should be performed
in a laboratory using a method that is
NGSP certified and standardized to the
DCCT assay.*
or
FPG 126 mg/dl (7.0 mmol/l). Fasting is
defined as no caloric intake for at least
8 h.*
or
2-h plasma glucose 200 mg/dl (11.1
mmol/l) during an OGTT. The test should
be performed as described by the World
Health Organization, using a glucose load
containing the equivalent of 75 g
anhydrous glucose dissolved in water.*
or
In a patient with classic symptoms of
hyperglycemia or hyperglycemic crisis, a
random plasma glucose 200 mg/dl (11.1
mmol/l)
*In the absence of unequivocal hyperglycemia, result should be confirmed by repeat testing.
S13
For many illnesses, there is a major distinction between screening and diagnostic testing. However, for diabetes, the
same tests would be used for screening
as for diagnosis. Diabetes may be identified anywhere along a spectrum of clinical
scenarios ranging from a seemingly lowrisk individual who happens to have glucose testing, to a higher-risk individual
whom the provider tests because of high
suspicion of diabetes, to the symptomatic
patient. The discussion herein is primarily framed as testing for diabetes in those
without symptoms. Testing for diabetes
will also detect individuals at increased
future risk for diabetes, herein referred to
as having prediabetes.
S14
Position Statement
Table 5Testing for type 2 diabetes in
asymptomatic children
Criteria
Overweight (BMI 85th percentile for
age and sex, weight for height 85th
percentile, or weight 120% of ideal for
height)
Plus any two of the following risk factors:
Family history of type 2 diabetes in firstor second-degree relative
Race/ethnicity (Native American, African
American, Latino, Asian American,
Pacific Islander)
Signs of insulin resistance or conditions
associated with insulin resistance
(acanthosis nigricans, hypertension,
dyslipidemia, PCOS, or small-forgestational-age birth weight)
Maternal history of diabetes or GDM
during the childs gestation
Age of initiation: age 10 years or at onset of
puberty, if puberty occurs at a younger
age
Frequency: every 3 years
S15
Study (ref.)
Lifestyle
Finnish DPS (14)
DPP (13)
Da Qing (15)
Toranomon Study
(35)
Indian DPP (19)
Medications
DPP (13)
Population
Mean
age
Duration
(years) (years)
51
46
54
43
55
56
Intervention
(daily dose)
Incidence in
control
subjects
(%/year)
Relative risk
reduction (%)
(95% CI)
3-Year
number
needed to
treat
3.2
3
I-D&E
I-D&E
6
10.4
58 (3070)
58 (4866)
8.5
6.9
6
4
G-D&E
I-D&E
14.5
2.4
38 (1456)
67 (P 0.043)
7.9
20.6
2.5
I-D&E
23
29 (2137)
6.4
10.4
31 (1743)
13.9
23
12.4
2.4
9.1
12.0
26 (1935)
25 (1037)
37 (1454)
60 (5465)
40 (1857)
6.9
9.6
45.5
6.9
21 (1-year
Rx)
2.8
Metformin (1,700
mg)
2.5
Metformin (500 mg)
3.2
Acarbose (300 mg)
4
Orlistat (360 mg)
3.0
Rosiglitazone (8 mg)
3.0 (1-year Vogliobose (0.2 mg)
Rx)
Modified and reprinted with permission (38). Percentage points: Number needed to treat to prevent 1 case of diabetes, standardized for a 3-year period to improve
comparisons across studies. *Number of participants in the indicated comparisons, not necessarily in entire study. Calculated from information in the article. DPP, Diabetes
Prevention Program; DPS, Diabetes Prevention Study; DREAM, Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication; STOP-NIDDM, Study to
Prevent Non-Insulin Dependent Diabetes; XENDOS, Xenical in the prevention of Diabetes in Obese Subjects. I, individual; G, group; D&E, diet and exercise.
IV. PREVENTION/DELAY
OF TYPE 2 DIABETES
Recommendations
Patients with IGT (A), IFG (E), or an
A1C of 5.7 6.4% (E) should be referred to an effective ongoing support
program targeting weight loss of 7% of
body weight and increasing physical
activity to at least 150 min/week of
moderate activity such as walking.
Follow-up counseling appears to be important for success. (B)
Based on potential cost savings of diabetes prevention, such programs should be
covered by third-party payors. (E)
Metformin therapy for prevention of
type 2 diabetes may be considered in
those at the highest risk for developing
diabetes, such as those with multiple
risk factors, especially if they demonstrate progression of hyperglycemia
(e.g., A1C 6%) despite lifestyle interventions. (B)
Monitoring for the development of diabetes in those with prediabetes should
be performed every year. (E)
Randomized controlled trials have shown
that individuals at high risk for developing diabetes (those with IFG, IGT, or
both) can be given interventions that significantly decrease the rate of onset of diS16
Position Statement
dition should be performed. A focus on
the components of comprehensive care
(Table 8) will assist the health care team to
ensure optimal management of the patient with diabetes.
B. Management
People with diabetes should receive medical care from a physician-coordinated
team. Such teams may include, but are
not limited to, physicians, nurse practitioners, physicians assistants, nurses, dietitians, pharmacists, and mental health
professionals with expertise and a special
interest in diabetes. It is essential in this
collaborative and integrated team approach that individuals with diabetes assume an active role in their care.
The management plan should be
formulated as a collaborative therapeutic alliance among the patient and family, the physician, and other members of
the health care team. A variety of strategies and techniques should be used to
provide adequate education and development of problem-solving skills in the
various aspects of diabetes management. Implementation of the management plan requires that each aspect is
understood and agreed to by the patient
and the care providers and that the goals
and treatment plan are reasonable. Any
plan should recognize diabetes selfmanagement education (DSME) and
ongoing diabetes support as an integral
component of care. In developing the
plan, consideration should be given to
the patients age, school or work schedule and conditions, physical activity,
eating patterns, social situation and
cultural factors, and presence of complications of diabetes or other medical
conditions.
C. Glycemic control
1. Assessment of glycemic control
Two primary techniques are available for
health providers and patients to assess the
effectiveness of the management plan on
glycemic control: patient self-monitoring
of blood glucose (SMBG) or interstitial
glucose, and A1C.
a. Glucose monitoring
Recommendations
SMBG should be carried out three or
more times daily for patients using multiple insulin injections or insulin pump
therapy. (A)
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S17
mg/dl
mmol/l
126
154
183
212
240
269
298
7.0
8.6
10.2
11.8
13.4
14.9
16.5
Position Statement
tes (51). The American Diabetes
Association and American Association of
Clinical Chemists have determined that
the correlation (r 0.92) is strong
enough to justify reporting both an A1C
result and an estimated average glucose
(eAG) result when a clinician orders the
A1C test. The table in previous versions of
the Standards of Medical Care in Diabetes
describing the correlation between A1C
and mean glucose was derived from relatively sparse data (one 7-point profile
over 1 day per A1C reading) in the primarily Caucasian type 1 diabetic participants in the DCCT (52). Clinicians
should note that the numbers in the table
are now different, as they are based on
2,800 readings per A1C in the ADAG
trial.
In the ADAG trial, there were no significant differences among racial and ethnic groups in the regression lines between
A1C and mean glucose, although there
was a trend toward a difference between
African/African American participants
and Caucasian ones that might have been
significant had more African/African
American participants been studied. A recent study comparing A1C with CGM
data in 48 type 1 diabetic children found
a highly statistically significant correlation between A1C and mean blood glucose, although the correlation (r 0.7)
was significantly lower than in the ADAG
trial (53). Whether there are significant
differences in how A1C relates to average
glucose in children or in African American patients is an area for further study.
For the time being, the question has not
led to different recommendations about
testing A1C or to different interpretations
of the clinical meaning of given levels of
A1C in those populations.
For patients in whom A1C/eAG and
measured blood glucose appear discrepant, clinicians should consider the possibilities of hemoglobinopathy or altered
red cell turnover, and the options of more
frequent and/or different timing of SMBG
or use of CGM. Other measures of chronic
glycemia such as fructosamine are available, but their linkage to average glucose
and their prognostic significance are not
as clear as is the case for A1C.
2. Glycemic goals in adults
Recommendations
Lowering A1C to below or around 7%
has been shown to reduce microvascular and neuropathic complications of
diabetes and, if implemented soon after
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S19
Position Statement
Table 10Summary of glycemic recommendations for many nonpregnant adults with
diabetes
7.0%*
70130 mg/dl* (3.97.2 mmol/l)
180 mg/dl* (10.0 mmol/l)
A1C
Preprandial capillary plasma glucose
Peak postprandial capillary plasma glucose
Goals should be individualized based on*:
duration of diabetes
age/life expectancy
comorbid conditions
known CVD or advanced microvascular
complications
hypoglycemia unawareness
individual patient considerations
More or less stringent glycemic goals may
be appropriate for individual patients.
Postprandial glucose may be targeted if
A1C goals are not met despite reaching
preprandial glucose goals.
Postprandial glucose measurements should be made 12 h after the beginning of the meal, generally peak
levels in patients with diabetes.
S21
Position Statement
Recommendations for management
of diabetes
Macronutrients in diabetes
management
The best mix of carbohydrate, protein,
and fat may be adjusted to meet the
metabolic goals and individual preferences of the person with diabetes. (E)
Monitoring carbohydrate, whether by
carbohydrate counting, choices, or experience-based estimation, remains a
key strategy in achieving glycemic control. (A)
For individuals with diabetes, the use of
the glycemic index and glycemic load
may provide a modest additional benefit for glycemic control over that observed when total carbohydrate is
considered alone. (B)
Saturated fat intake should be 7% of
total calories. (A)
Reducing intake of trans fat lowers LDL
cholesterol and increases HDL cholesterol (A), therefore intake of trans fat
should be minimized. (E)
Other nutrition recommendations
If adults with diabetes choose to use
alcohol, daily intake should be limited
to a moderate amount (one drink per
day or less for adult women and two
drinks per day or less for adult men).
(E)
Routine supplementation with antioxidants, such as vitamins E and C and
carotene, is not advised because of lack
of evidence of efficacy and concern related to long-term safety. (A)
Individualized meal planning should
include optimization of food choices to
meet recommended dietary allowance
(RDA)/dietary reference intake (DRI)
for all micronutrients. (E)
S23
Position Statement
creased risk of skin breakdown and infection and of Charcot joint destruction.
Prior recommendations have advised
nonweight-bearing exercise for patients
with severe peripheral neuropathy. However, studies have shown that moderateintensity walking may not lead to
increased risk of foot ulcers or reulceration in those with peripheral neuropathy (157). All individuals with
peripheral neuropathy should wear
proper footwear and examine their feet
daily to detect lesions early. Anyone with
a foot injury or open sore should be restricted to nonweight-bearing activities.
Autonomic neuropathy. Autonomic neuropathy can increase the risk of exerciseinduced injury or adverse event through
decreased cardiac responsiveness to exercise, postural hypotension, impaired
thermoregulation, impaired night vision
due to impaired papillary reaction, and
unpredictable carbohydrate delivery from
gastroparesis predisposing to hypoglycemia (158). Autonomic neuropathy is also
strongly associated with CVD in people
with diabetes (159,160). People with diabetic autonomic neuropathy should undergo cardiac investigation before
beginning physical activity more intense
than that to which they are accustomed.
Albuminuria and nephropathy. Physical
activity can acutely increase urinary protein excretion. However, there is no evidence that vigorous exercise increases the
rate of progression of diabetic kidney disease, and there is likely no need for any
specific exercise restrictions for people
with diabetic kidney disease (161).
H. Psychosocial assessment and care
Recommendations
Assessment of psychological and social
situation should be included as an ongoing part of the medical management
of diabetes. (E)
Psychosocial screening and follow-up
should include, but is not limited to,
attitudes about the illness, expectations
for medical management and outcomes, affect/mood, general and diabetes-related quality of life, resources
(financial, social, and emotional), and
psychiatric history. (E)
Screen for psychosocial problems such
as depression and diabetes-related distress, anxiety, eating disorders, and
cognitive impairment when selfmanagement is poor. (C)
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S25
K. Intercurrent illness
The stress of illness, trauma, and/or surgery frequently aggravates glycemic control and may precipitate diabetic
ketoacidosis (DKA) or nonketotic hyperosmolar state, life-threatening conditions
that require immediate medical care to
prevent complications and death. Any
condition leading to deterioration in glycemic control necessitates more frequent
monitoring of blood glucose and (in ketosis-prone patients) urine or blood ketones. Marked hyperglycemia requires
temporary adjustment of the treatment
program and, if accompanied by ketosis,
vomiting, or alteration in level of consciousness, immediate interaction with
the diabetes care team. The patient treated
with noninsulin therapies or MNT alone
may temporarily require insulin. Adequate fluid and caloric intake must be assured. Infection or dehydration are more
likely to necessitate hospitalization of the
person with diabetes than the person
without diabetes.
The hospitalized patient should be
treated by a physician with expertise in
the management of diabetes. For further
information on management of patients
with hyperglycemia in the hospital, see
VIII.A. Diabetes care in the hospital. For
further information on management of
DKA or nonketotic hyperosmolar state,
refer to the ADA consensus statement on
hyperglycemic crises (172).
L. Bariatric surgery
Recommendations
Bariatric surgery may be considered for
adults with BMI 35 kg/m2 and type 2
diabetes, especially if the diabetes or associated comorbidities are difficult to
control with lifestyle and pharmacologic therapy. (B)
Patients with type 2 diabetes who have
undergone bariatric surgery need lifelong lifestyle support and medical
monitoring. (E)
Although small trials have shown glycemic benefit of bariatric surgery in patients with type 2 diabetes and BMI of
30 35 kg/m2, there is currently insufficient evidence to generally recommend surgery in patients with BMI 35
kg/m2 outside of a research protocol.
(E)
T h e l o n g - t e r m b e n e fi t s , c o s t effectiveness, and risks of bariatric surgery in individuals with type 2 diabetes
should be studied in well-designed
controlled trials with optimal medical
Position Statement
roscopic cholecystectomy (180). Longerterm concerns include vitamin and
mineral deficiencies, osteoporosis, and
rare but often severe hypoglycemia from
insulin hypersecretion. Cohort studies attempting to match subjects suggest that
the procedure may reduce longer-term
mortality rates (181), and it is reasonable
to postulate that there may be recouping
of costs over the long run. Recent retrospective analyses and modeling studies
suggest that these procedures may be cost
effective, when one considers reduction
in subsequent health care costs (182
184). However, studies of the mechanisms of glycemic improvement and
long-term benefits and risks of bariatric
surgery in individuals with type 2 diabetes, especially those who are not severely
obese, will require well-designed clinical
trials, with optimal medical and lifestyle
therapy of diabetes and cardiovascular
risk factors as the comparator.
M. Immunization
Recommendations
Annually provide an influenza vaccine
to all diabetic patients at least 6 months
of age. (C)
Administer pneumococcal polysaccharide vaccine to all diabetic patients 2
years of age. A one-time revaccination is
recommended for individuals 64
years of age previously immunized
when they were 65 years of age if the
vaccine was administered 5 years
ago. Other indications for repeat vaccination include nephrotic syndrome,
chronic renal disease, and other immunocompromised states, such as after
transplantation. (C)
Influenza and pneumonia are common,
preventable infectious diseases associated
with high mortality and morbidity in the
elderly and in people with chronic diseases. Though there are limited studies
reporting the morbidity and mortality of
influenza and pneumococcal pneumonia
specifically in people with diabetes, observational studies of patients with a variety of chronic illnesses, including
diabetes, show that these conditions are
associated with an increase in hospitalizations for influenza and its complications.
People with diabetes may be at increased
risk of the bacteremic form of pneumococcal infection and have been reported
to have a high risk of nosocomial bacteremia, which has a mortality rate as high as
50% (185).
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Safe and effective vaccines are available that can greatly reduce the risk of
serious complications from these diseases
(186,187). In a case-control series, influenza vaccine was shown to reduce diabetes-related hospital admission by as much
as 79% during flu epidemics (186). There
is sufficient evidence to support that people with diabetes have appropriate serologic and clinical responses to these
vaccinations. The Centers for Disease
Control and Prevention (CDC) Advisory
Committee on Immunization Practices
recommends influenza and pneumococcal vaccines for all individuals with diabetes (http://www.cdc.gov/vaccines/recs/).
VI. PREVENTION AND
MANAGEMENT OF
DIABETES COMPLICATIONS
A. CVD
CVD is the major cause of morbidity and
mortality for individuals with diabetes,
and the largest contributor to the direct
and indirect costs of diabetes. The common conditions coexisting with type 2
diabetes (e.g., hypertension and dyslipidemia) are clear risk factors for CVD, and
diabetes itself confers independent risk.
Numerous studies have shown the efficacy of controlling individual cardiovascular risk factors in preventing or slowing
CVD in people with diabetes. Large benefits are seen when multiple risk factors
are addressed globally (188,189). Risk for
coronary heart disease (CHD) and for
CVD in general can be estimated using
multivariable risk factor approaches, and
such a strategy may be desirable to undertake in adult patients prior to instituting
preventive therapy.
1. Hypertension/blood pressure
control
Recommendations
Screening and diagnosis
Blood pressure should be measured at
every routine diabetes visit. Patients
found to have systolic blood pressure
130 mmHg or diastolic blood pressure 80 mmHg should have blood
pressure confirmed on a separate day.
Repeat systolic blood pressure 130
mmHg or diastolic blood pressure 80
mmHg confirms a diagnosis of hypertension. (C)
Goals
A goal systolic blood pressure 130
mmHg is appropriate for most patients
with diabetes. (C)
Based on patient characteristics and response to therapy, higher or lower systolic blood pressure targets may be
appropriate. (B)
Patients with diabetes should be treated
to a diastolic blood pressure 80
mmHg. (B)
Treatment
Patients with a systolic blood pressure
of 130 139 mmHg or a diastolic blood
pressure of 80 89 mmHg may be given
lifestyle therapy alone for a maximum
of 3 months and then, if targets are not
achieved, be treated with addition of
pharmacological agents. (E)
Patients with more severe hypertension
(systolic blood pressure 140 or diastolic blood pressure 90 mmHg) at
diagnosis or follow-up should receive
pharmacologic therapy in addition to
lifestyle therapy. (A)
Lifestyle therapy for hypertension consists of: weight loss, if overweight; Dietary Approaches to Stop Hypertension
(DASH)-style dietary pattern including
reducing sodium and increasing potassium intake; moderation of alcohol intake; and increased physical activity.
(B)
Pharmacologic therapy for patients
with diabetes and hypertension should
be with a regimen that includes either
an ACE inhibitor or an ARB. If one class
is not tolerated, the other should be
substituted. If needed to achieve blood
pressure targets, a thiazide diuretic
should be added to those with an estimated GFR (eGFR) (see below) 30
ml/min/1.73 m2 and a loop diuretic for
those with an eGFR 30 ml/min/1.73
m2. (C)
Multiple drug therapy (two or more
agents at maximal doses) is generally
required to achieve blood pressure targets. (B)
If ACE inhibitors, ARBs, or diuretics are
used, kidney function and serum potassium levels should be monitored. (E)
In pregnant patients with diabetes and
chronic hypertension, blood pressure
target goals of 110 129/6579 mmHg
are suggested in the interest of longterm maternal health and minimizing
impaired fetal growth. ACE inhibitors
and ARBs are contraindicated during
pregnancy. (E)
S27
Position Statement
channel blockers, has been shown to be
effective in reducing cardiovascular
events. Several studies suggested that
ACE inhibitors may be superior to dihydropyridine calcium channel blockers in
reducing cardiovascular events (202
204). However, a variety of other studies
have shown no specific advantage to ACE
inhibitors as initial treatment of hypertension in the general hypertensive population, but rather an advantage on
cardiovascular outcomes of initial therapy
with low-dose thiazide diuretics
(190,205,206).
In people with diabetes, inhibitors of
the renin-angiotensin system (RAS) may
have unique advantages for initial or early
therapy of hypertension. In a nonhypertension trial of high-risk individuals, including a large subset with diabetes, an
ACE inhibitor reduced CVD outcomes
(207). In patients with congestive heart
failure (CHF), including diabetic subgroups, ARBs have been shown to reduce
major CVD outcomes (208 211), and in
type 2 patients with significant nephropathy, ARBs were superior to calcium
channel blockers for reducing heart failure (212). Though evidence for distinct
advantages of RAS inhibitors on CVD outcomes in diabetes remains conflicting
(195,206), the high CVD risks associated
with diabetes, and the high prevalence of
undiagnosed CVD, may still favor recommendations for their use as first-line hypertension therapy in people with
diabetes (190). Recently, the blood pressure arm of the ADVANCE trial demonstrated that routine administration of a
fixed combination of the ACE inhibitor
perindopril and the diuretic indapamide
significantly reduced combined microvascular and macrovascular outcomes, as
well as CVD and total mortality. The improved outcomes could also have been
due to lower achieved blood pressure in
the perindopril-indapamide arm (199).
In addition, the Avoiding Cardiovascular
Events through Combination Therapy in
Patients Living with Systolic Hypertension (ACCOMPLISH) trial showed a decrease in morbidity and mortality in those
receiving benazapril and amlodipine versus benazapril and hydrochlorothiazide.
The compelling benefits of RAS inhibitors
in diabetic patients with albuminuria or
renal insufficiency provide additional rationale for use of these agents (see VI.B.
Nephropathy screening and treatment).
An important caveat is that most patients with hypertension require multidrug therapy to reach treatment goals,
care.diabetesjournals.org
2. Dyslipidemia/lipid management
Recommendations
Screening
In most adult patients, measure fasting
lipid profile at least annually. In adults
with low-risk lipid values (LDL cholesterol 100 mg/dl, HDL cholesterol
50 mg/dl, and triglycerides 150
mg/dl), lipid assessments may be repeated every 2 years. (E)
S29
Study (ref.)
CVD
4S-DM (215)
ASPEN 2 (220)
HPS-DM (216)
CARE-DM (217)
TNT-DM (218)
HPS-DM (216)
CARDS (221)
ASPEN 1 (220)
ASCOT-DM (219)
Risk
reduction (%)
Relative risk
reduction (%)
Absolute risk
reduction (%)
LDL cholesterol
reduction (mg/dl)
LDL cholesterol
reduction (%)
Simvastatin 2040 mg
vs. placebo
Atorvastatin 10 mg vs.
placebo
Simvastatin 40 mg vs.
placebo
Pravastatin 40 mg vs.
placebo
Atorvastatin 80 mg vs.
10 mg
Simvastatin 40 mg vs.
placebo
Atorvastatin 10 mg vs.
placebo
Atorvastatin 10 mg vs.
placebo
Atorvastatin 10 mg vs.
placebo
85.7 to 43.2
50
42.5
186 to 119
36
39.5 to 24.5
34
15
112 to 79
29
43.8 to 36.3
17
7.5
123 to 84
31
40.8 to 35.4
13
5.4
136 to 99
27
26.3 to 21.6
18
4.7
99 to 77
22
17.5 to 11.5
34
6.0
124 to 86
31
11.5 to 7.5
35
118 to 71
40
9.8 to 7.9
19
1.9
114 to 80
30
11.1 to 10.2
0.9
125 to 82
34
Studies were of differing lengths (3.35.4 years) and used somewhat different outcomes, but all reported rates of CVD death and nonfatal MI. In this tabulation,
results of the statin on 10-year risk of major CVD endpoints (CHD death/nonfatal MI) are listed for comparison between studies. Correlation between 10-year CVD
risk of the control group and the absolute risk reduction with statin therapy is highly significant (P 0.0007). Analyses provided by Craig Williams, PharmD, Oregon
Health & Science University, 2007.
els, are the most prevalent pattern of dyslipidemia in persons with type 2 diabetes.
However, the evidence base for drugs that
target these lipid fractions is significantly
less robust than that for statin therapy
(222). Nicotinic acid has been shown to
reduce CVD outcomes (223), although
the study was done in a nondiabetic cohort. Gemfibrozil has been shown to decrease rates of CVD events in subjects
without diabetes (224,225) and in the diabetic subgroup in one of the larger trials
(224). However, in a large trial specific to
diabetic patients, fenofibrate failed to reduce overall cardiovascular outcomes
(226).
Dyslipidemia treatment and target
lipid levels
For most patients with diabetes, the first
priority of dyslipidemia therapy (unless
severe hypertriglyceridemia is the immediate issue) is to lower LDL cholesterol to
a target goal of 100 mg/dl (2.60 mmol/l)
(227). Lifestyle intervention, including
MNT, increased physical activity, weight
loss, and smoking cessation, may allow
some patients to reach lipid goals. Nutrition intervention should be tailored according to each patients age, type of
diabetes, pharmacological treatment,
lipid levels, and other medical conditions
and should focus on the reduction of satS30
urated fat, cholesterol, and trans unsaturated fat intake and increases in omega-3
fatty acids, viscous fiber (such as in oats,
legumes, citrus), and plant stanols/
sterols. Glycemic control can also beneficially modify plasma lipid levels,
particularly in patients with very high
triglycerides and poor glycemic control.
In those with clinical CVD or over age
40 years with other CVD risk factors,
pharmacological treatment should be
added to lifestyle therapy regardless of
baseline lipid levels. Statins are the drugs
of choice for LDL cholesterol lowering.
In patients other than those described
above, statin treatment should be considered if there is an inadequate LDL cholesterol response to lifestyle modifications
and improved glucose control, or if the
patient has increased cardiovascular risk
(e.g., multiple cardiovascular risk factors
or long duration of diabetes). Very little
clinical trial evidence exists for type 2 diabetic patients under age 40 years or for
type 1 patients of any age. In the Heart
Protection Study (lower age limit 40
years), the subgroup of 600 patients with
type 1 diabetes had a proportionately similar reduction in risk as patients with type
2 diabetes, although not statistically significant (216). Although the data are not
definitive, consideration should be given
to similar lipid-lowering goals in type 1
diabetic patients as in type 2 diabetic patients, particularly if they have other cardiovascular risk factors.
Alternative LDL cholesterol goals
Virtually all trials of statins and CVD outcomes tested specific doses of statins
against placebo, other doses of statin, or
other statins, rather than aiming for specific LDL cholesterol goals (228). As can
be seen in Table 11, placebo-controlled
trials generally achieved LDL cholesterol
reductions of 30 40% from baseline.
Hence, LDL cholesterol lowering of this
magnitude is an acceptable outcome for
patients who cannot reach LDL cholesterol goals due to severe baseline elevations in LDL cholesterol and/or
intolerance of maximal, or any, statin
doses. Additionally for those with baseline LDL cholesterol minimally above 100
mg/dl, prescribing statin therapy to lower
LDL cholesterol about 30 40% from
baseline is probably more effective than
prescribing just enough to get LDL cholesterol slightly below 100 mg/dl.
Recent clinical trials in high-risk patients, such as those with acute coronary
syndromes or previous cardiovascular
events (229 231), have demonstrated
that more aggressive therapy with high
doses of statins to achieve an LDL cholesterol of 70 mg/dl led to a significant recare.diabetesjournals.org
Position Statement
duction in further events. Therefore, a
reduction in LDL cholesterol to a goal of
70 mg/dl is an option in very-high-risk
diabetic patients with overt CVD (232).
In individual patients, LDL cholesterol lowering with statins is highly variable, and this variable response is poorly
understood (233). Reduction of CVD
events with statins correlates very closely
with LDL cholesterol lowering (214).
When maximally tolerated doses of statins fail to significantly lower LDL cholesterol (30% reduction from patients
baseline), the primary aim of combination
therapy should be to achieve additional
LDL cholesterol lowering. Niacin, fenofibrate, ezetimibe, and bile acid sequestrants all offer additional LDL cholesterol
lowering. The evidence that combination
therapy provides a significant increment
in CVD risk reduction over statin therapy
alone is still elusive.
In 2008, a consensus panel convened
by the American Diabetes Association and
the American College of Cardiology recommended a greater focus on non-HDL
cholesterol and apo lipoprotein B (apo B)
in patients who are likely to have small
LDL particles, such as people with diabetes (234). The consensus panel suggested
that for statin-treated patients in whom
the LDL cholesterol goal would be 70
mg/dl (non-HDL cholesterol 100 mg/
dl), apo B should be measured and treated
to 80 mg/dl. For patients on statins with
an LDL cholesterol goal of 100 mg/dl
(non-HDL cholesterol 130 mg/dl), apo
B should be measured and treated to 90
mg/dl.
3. Antiplatelet agents
care.diabetesjournals.org
Combination therapy
Combination therapy, with a statin and a
fibrate or statin and niacin, may be efficacious for treatment for all three lipid fractions, but this combination is associated
with an increased risk for abnormal
transaminase levels, myositis, or rhabdomyolysis. The risk of rhabdomyolysis is
higher with higher doses of statins and
with renal insufficiency and seems to be
lower when statins are combined with fenofibrate than gemfibrozil (237). In the
recent ACCORD study, the combination
of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular
events, nonfatal myocardial infarction, or
nonfatal stroke, as compared with simvastatin alone, in patients with type 2 diabetes who were at high risk for CVD.
However, prespecified subgroup analyses
suggested heterogeneity in treatment effects according to sex, with a benefit for
men and possible harm for women, and a
possible benefit of combination therapy
for patients with both triglyceride level
204 mg/dl and HDL cholesterol level
34 mg/dl (238). Other ongoing trials
may provide much-needed evidence for
the effects of combination therapy on cardiovascular outcomes.
Table 12 summarizes common treatment
goals for A1C, blood pressure, and HDL
cholesterol.
Recommendations
Consider aspirin therapy (75162 mg/
day) as a primary prevention strategy in
those with type 1 or type 2 diabetes at
increased cardiovascular risk (10-year
risk 10%). This includes most men
50 years of age or women 60 years
of age who have at least one additional
major risk factor (family history of
CVD, hypertension, smoking, dyslipidemia, or albuminuria). (C)
Aspirin should not be recommended
for CVD prevention for adults with diabetes at low CVD risk (10-year CVD
risk 5%, such as in men 50 and
women 60 years of age with no major
additional CVD risk factors), since the
potential adverse effects from bleeding
likely offset the potential benefits. (C)
In patients in these age-groups with
7.0%*
130/80 mmHg
100 mg/dl
(2.6 mmol/l)
*More or less stringent glycemic goals may be appropriate for individual patients. Goals should be
individualized based on: duration of diabetes, age/
life expectancy, comorbid conditions, known CVD
or advanced microvascular complications, hypoglycemia unawareness, and individual patient considerations. Based on patient characteristics and
response to therapy, higher or lower systolic blood
pressure targets may be appropriate. In individuals
with overt CVD, a lower LDL cholesterol goal of
70 mg/dl (1.8 mmol/l), using a high dose of a
statin, is an option.
S31
and health risks. Much of the work documenting the impact of smoking on
health did not separately discuss results
on subsets of individuals with diabetes,
but suggests that the identified risks are at
least equivalent to those found in the general population. Other studies of individuals with diabetes consistently
demonstrate that smokers have a heightened risk of CVD, premature death, and
increased rate of microvascular complications of diabetes. Smoking may have a
role in the development of type 2 diabetes.
The routine and thorough assessment of tobacco use is important as a
means of preventing smoking or encouraging cessation. A number of large
randomized clinical trials have demonstrated the efficacy and cost-effectiveness of brief counseling in smoking
cessation, including the use of quit
lines, in the reduction of tobacco use.
For the patient motivated to quit, the
addition of pharmacological therapy to
counseling is more effective than either
treatment alone. Special considerations
should include assessment of level of
nicotine dependence, which is associated with difficulty in quitting and relapse (247).
5. CHD screening and treatment
Recommendations
Screening
In asymptomatic patients, routine
screening for CAD is not recommended, as it does not improve outcomes as long as CVD risk factors are
treated. (A)
Treatment
In patients with known CVD, ACE inhibitor (C) and aspirin and statin therapy (A) (if not contraindicated) should
be used to reduce the risk of cardiovascular events.
In patients with a prior myocardial infarction, -blockers should be continued for at least 2 years after the event
(B).
Longer term use of -blockers in the
absence of hypertension is reasonable if
well tolerated, but data are lacking. (E)
Avoid TZD treatment in patients with
symptomatic heart failure. (C)
Metformin may be used in patients with
stable CHF if renal function is normal.
It should be avoided in unstable or hospitalized patients with CHF. (C)
care.diabetesjournals.org
Position Statement
Screening for CAD is reviewed in a recently updated consensus statement
(154). To identify the presence of CAD
in diabetic patients without clear or
suggestive symptoms, a risk factor
based approach to the initial diagnostic
evaluation and subsequent follow-up
has intuitive appeal. However, recent
studies concluded that using this approach fails to identify which patients
with type 2 diabetes will have silent
ischemia on screening tests (159,248).
Candidates for cardiac testing include those with 1) typical or atypical
cardiac symptoms and 2) an abnormal
resting ECG. The screening of asymptomatic patients remains controversial,
especially as intensive medical therapy,
indicated in diabetic patients at high
risk for CVD, has an increasing evidence
base for providing equal outcomes to
invasive revascularization, including in
diabetic patients (249,250). There is
also some evidence that silent myocardial ischemia may reverse over time,
adding to the controversy concerning
aggressive screening strategies (251).
Finally, a recent randomized observational trial demonstrated no clinical
benefit to routine screening of asymptomatic patients with type 2 diabetes
and normal ECGs (252). Despite abnormal myocardial perfusion imaging in
more than one in five patients, cardiac
outcomes were essentially equal (and
very low) in screened versus unscreened patients. Accordingly, the
overall effectiveness, especially the
cost-effectiveness, of such an indiscriminate screening strategy is now questioned.
Newer noninvasive CAD screening
methods, such as computed tomography (CT) and CT angiography have
gained in popularity. These tests infer
the presence of coronary atherosclerosis
by measuring the amount of calcium in
coronary arteries and, in some circumstances, by direct visualization of luminal stenoses. Although asymptomatic
diabetic patients found to have a higher
coronary disease burden have more future cardiac events (253255), the role
of these tests beyond risk stratification
is not clear. Their routine use leads to
radiation exposure and may result in
unnecessary invasive testing such as
coronary angiography and revascularization procedures. The ultimate balance of benefit, cost, and risks of such
an approach in asymptomatic patients
remains controversial, particularly in
care.diabetesjournals.org
Recommendations
General recommendations
To reduce the risk or slow the progression of nephropathy, optimize glucose
control. (A)
To reduce the risk or slow the progression of nephropathy, optimize blood
pressure control. (A)
Screening
Perform an annual test to assess urine
albumin excretion in type 1 diabetic patients with diabetes duration of 5 years
and in all type 2 diabetic patients starting at diagnosis. (E)
Measure serum creatinine at least annually in all adults with diabetes regardless of the degree of urine albumin
excretion. The serum creatinine should
be used to estimate GFR and stage the
level of chronic kidney disease (CKD),
if present. (E)
Treatment
In the treatment of the nonpregnant patient with micro- or macroalbuminuria,
either ACE inhibitors or ARBs should
be used. (A)
While there are no adequate head-tohead comparisons of ACE inhibitors
and ARBs, there is clinical trial support
for each of the following statements:
In patients with type 1 diabetes, with
hypertension and any degree of albu
S33
Category
Normal
Microalbuminuria
Macro (clinical)-albuminuria
30
30299
300
Stage
1
2
3
4
5
Description
90
6089
3059
1529
15 or dialysis
*Kidney damage defined as abnormalities on pathologic, urine, blood, or imaging tests. Adapted from ref.
284.
care.diabetesjournals.org
Position Statement
Complications of kidney disease correlate with level of kidney function. When
the eGFR is less than 60 ml/min/1.73 m2,
screening for complications of CKD is indicated (Table 15). Early vaccination
against hepatitis B is indicated in patients
likely to progress to end-stage kidney disease.
Consider referral to a physician experienced in the care of kidney disease
when there is uncertainty about the etiology of kidney disease (heavy proteinuria, active urine sediment, absence of
retinopathy, rapid decline in GFR, resistant hypertension), difficult management issues, or advanced kidney
disease. The threshold for referral may
vary depending on the frequency with
which a provider encounters diabetic
patients with significant kidney disease.
Consultation with a nephrologist when
stage 4 CKD develops has been found to
reduce cost, improve quality of care,
and keep people off dialysis longer
(289). However, nonrenal specialists
should not delay educating their patients about the progressive nature of
diabetic kidney disease; the renal preservation benefits of aggressive treatment of blood pressure, blood glucose,
and hyperlipidemia; and the potential
need for renal replacement therapy.
3044
30
Recommendations
Screening
Adults and children aged 10 years or
older with type 1 diabetes should have
an initial dilated and comprehensive
eye examination by an ophthalmologist
or optometrist within 5 years after the
onset of diabetes. (B)
Patients with type 2 diabetes should
have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist shortly after the
diagnosis of diabetes. (B)
Subsequent examinations for type 1
and type 2 diabetic patients should be
repeated annually by an ophthalmologist or optometrist. Less frequent exams
care.diabetesjournals.org
General recommendations
To reduce the risk or slow the progression of retinopathy, optimize glycemic
control. (A)
To reduce the risk or slow the progression of retinopathy, optimize blood
pressure control. (A)
Recommended
Treatment
Promptly refer patients with any level of
macular edema, severe NPDR, or any
PDR to an ophthalmologist who is
knowledgeable and experienced in the
management and treatment of diabetic
retinopathy. (A)
Laser photocoagulation therapy is indicated to reduce the risk of vision loss in
S35
The diabetic neuropathies are heterogeneous with diverse clinical manifestations. They may be focal or diffuse. Most
common among the neuropathies are
chronic sensorimotor DPN and autonomic neuropathy. Although DPN is a diagnosis of exclusion, complex
investigations to exclude other conditions
are rarely needed.
The early recognition and appropriate management of neuropathy in the pa-
Position Statement
vascular autonomic neuropathy may be
indicated by resting tachycardia (100
bpm) or orthostasis (a fall in systolic
blood pressure 20 mmHg upon standing without an appropriate heart rate response); it is also associated with
increased cardiac event rates.
Gastrointestinal neuropathies (e.g.,
esophageal enteropathy, gastroparesis,
constipation, diarrhea, fecal incontinence) are common, and any section of
the gastrointestinal tract may be affected.
Gastroparesis should be suspected in individuals with erratic glucose control or
with upper gastrointestinal symptoms
without other identified cause. Evaluation of solid-phase gastric emptying using
double-isotope scintigraphy may be done
if symptoms are suggestive, but test results often correlate poorly with symptoms. Constipation is the most common
lower-gastrointestinal symptom but can
alternate with episodes of diarrhea.
Diabetic autonomic neuropathy is
also associated with genitourinary tract
disturbances. In men, diabetic autonomic
neuropathy may cause erectile dysfunction and/or retrograde ejaculation. Evaluation of bladder dysfunction should be
performed for individuals with diabetes
who have recurrent urinary tract infections, pyelonephritis, incontinence, or a
palpable bladder.
Symptomatic treatments
DPN. The first step in management of patients with DPN should be to aim for stable and optimal glycemic control.
Although controlled trial evidence is lacking, several observational studies suggest
that neuropathic symptoms improve not
only with optimization of control, but
also with the avoidance of extreme blood
glucose fluctuations. Patients with painful
DPN may benefit from pharmacological
treatment of their symptoms: many
agents have efficacy confirmed in published randomized controlled trials, several of which are Food and Drug
Administration (FDA)-approved for the
management of painful DPN.
Treatment of autonomic neuropathy
Gastroparesis symptoms may improve
with dietary changes and prokinetic
agents such as metoclopramide or erythromycin. Treatments for erectile dysfunction may include phosphodiesterase type
5 inhibitors, intracorporeal or intraurethral prostaglandins, vacuum devices, or
penile prostheses. Interventions for other
manifestations of autonomic neuropathy
care.diabetesjournals.org
Previous amputation
Past foot ulcer history
Peripheral neuropathy
Foot deformity
Peripheral vascular disease
Visual impairment
Diabetic nephropathy (especially patients on dialysis)
Poor glycemic control
Cigarette smoking
Many studies have been published proposing a range of tests that might usefully
identify patients at risk of foot ulceration,
creating confusion among practitioners as
to which screening tests should be
adopted in clinical practice. An ADA task
force was therefore assembled in 2008 to
concisely summarize recent literature in
this area and then recommend what
should be included in the comprehensive
foot exam for adult patients with diabetes.
Their recommendations are summarized
below, but clinicians should refer to the
task force report (305) for further details
and practical descriptions of how to perform components of the comprehensive
foot examination.
At least annually, all adults with diabetes should undergo a comprehensive
foot examination to identify high risk
conditions. Clinicians should ask about
history of previous foot ulceration or amputation, neuropathic or peripheral vascular symptoms, impaired vision, tobacco
use, and foot care practices. A general inspection of skin integrity and musculoskeletal deformities should be done in a
well lit room. Vascular assessment would
include inspection and assessment of
pedal pulses.
The neurologic exam recommended
is designed to identify loss of protective
sensation (LOPS) rather than early neuropathy. The clinical examination to identify LOPS is simple and requires no
expensive equipment. Five simple clinical
tests (use of a 10-g monofilament, vibration testing using a 128-Hz tuning fork,
tests of pinprick sensation, ankle reflex
assessment, and testing vibration perception threshold with a biothesiometer),
each with evidence from well-conducted
prospective clinical cohort studies, are
considered useful in the diagnosis of
LOPS in the diabetic foot. The task force
agrees that any of the five tests listed could
be used by clinicians to identify LOPS,
although ideally two of these should be
regularly performed during the screening
examnormally the 10-g monofilament
and one other test. One or more abnormal
tests would suggest LOPS, while at least
two normal tests (and no abnormal test)
would rule out LOPS. The last test listed,
vibration assessment using a biothesiometer or similar instrument, is widely used
S37
a. Glycemic control
Recommendations
Consider age when setting glycemic
goals in children and adolescents with
type 1 diabetes. (E)
care.diabetesjournals.org
Position Statement
Table 16Plasma blood glucose and A1C goals for type 1 diabetes by age-group
Plasma blood glucose goal range
(mg/dl)
Before meals
Bedtime/overnight
A1C (%)
Rationale
100180
110200
8.5
Vulnerability to hypoglycemia
Insulin sensitivity
Unpredictability in dietary intake and
physical activity
A lower goal (8.0%) is reasonable if
it can be achieved without excessive
hypoglycemia
90180
100180
Vulnerability to hypoglycemia
A lower goal (7.5%) is reasonable if
it can be achieved without excessive
hypoglycemia
90130
90150
7.5
ii. Hypertension
Recommendations
Treatment of high-normal blood
pressure (systolic or diastolic blood
pressure consistently above the 90th
percentile for age, sex, and height)
should include dietary intervention
and exercise aimed at weight control
and increased physical activity, if appropriate. If target blood pressure is
not reached with 3 6 months of lifestyle intervention, pharmacologic
treatment should be considered. (E)
Pharmacologic treatment of hypertension (systolic or diastolic blood
pressure consistently above the 95th
care.diabetesjournals.org
It is important that blood pressure measurements are determined correctly, using the appropriate size cuff, and with
the child seated and relaxed. Hypertension should be confirmed on at least
three separate days. Normal blood pressure levels for age, sex, and height and
appropriate methods for determinations are available online at www.nhlbi.
nih.gov/health/prof/heart/hbp/hbp_
ped.pdf.
iii. Dyslipidemia
Recommendations
Screening
If there is a family history of hypercholesterolemia (total cholesterol 240
mg/dl) or a cardiovascular event before
age 55 years, or if family history is unknown, then a fasting lipid profile
should be performed on children 2
years of age soon after diagnosis (after
glucose control has been established).
If family history is not of concern, then
the first lipid screening should be considered at puberty (10 years). All children diagnosed with diabetes at or after
puberty should have a fasting lipid profile performed soon after diagnosis
(after glucose control has been established). (E)
For both age-groups, if lipids are abnormal, annual monitoring is recommended. If LDL cholesterol values are
within the accepted risk levels (100
mg/dl [2.6 mmol/l]), a lipid profile
should be repeated every 5 years. (E)
S39
iv. Retinopathy
Recommendations
The first ophthalmologic examination
should be obtained once the child is 10
years of age and has had diabetes for
35 years. (E)
After the initial examination, annual
routine follow-up is generally recommended. Less frequent examinations
may be acceptable on the advice of an
eye care professional. (E)
S40
v. Celiac disease
Recommendations
Children with type 1 diabetes should
be screened for celiac disease by measuring tissue transglutaminase or
anti-endomysial antibodies, with
documentation of normal total serum
IgA levels, soon after the diagnosis of
diabetes. (E)
Testing should be repeated in children
with growth failure, failure to gain
weight, weight loss, diarrhea, flatulence, abdominal pain, or signs of malabsorption, or in children with
frequent unexplained hypoglycemia or
deterioration in glycemic control. (E)
Children with positive antibodies
should be referred to a gastroenterologist for evaluation with endoscopy and
biopsy. (E)
Children with biopsy-confirmed celiac
disease should be placed on a glutenfree diet and have consultation with a
dietitian experienced in managing both
diabetes and celiac disease. (E)
Celiac disease is an immune-mediated
disorder that occurs with increased frequency in patients with type 1 diabetes
(116% of individuals compared with
0.31% in the general population)
(326,327). Symptoms of celiac disease include diarrhea, weight loss or poor weight
gain, growth failure, abdominal pain,
chronic fatigue, malnutrition due to malabsorption, other gastrointestinal problems, and unexplained hypoglycemia or
erratic blood glucose concentrations.
The advent of routine periodic
screening has led to the diagnosis of celiac
disease in asymptomatic children. While
several studies have documented shortterm benefits of gluten restriction on
growth and bone mineral density in
asymptomatic children diagnosed with
celiac disease by routine screening, there
is little literature available regarding the
Position Statement
e. Transition from pediatric to adult
care
As they approach the young adult years,
older adolescents are at increasing physical, behavioral, and other risks (333,334).
As they leave both their home and their
pediatric diabetes care providers, these
older teens may become disengaged from
the health care system, leading to lapses in
medical care and deterioration in glycemic control (335). Though scientific evidence is limited to date, it is clear that
early and ongoing attention be given to
comprehensive and coordinated planning
for seamless transition of all youth from
pediatric to adult health care (336,337).
The National Diabetes Education Program (NDEP) has materials available to
facilitate this transition process (http://
ndep.nih.gov/transitions/).
2. Type 2 diabetes
The incidence of type 2 diabetes in adolescents is increasing, especially in ethnic
minority populations (21). Distinction
between type 1 and type 2 diabetes in
children can be difficult, since the prevalence of overweight in children continues
to rise and since autoantigens and ketosis
may be present in a substantial number of
patients with features of type 2 diabetes
(including obesity and acanthosis nigricans). Such a distinction at the time of
diagnosis is critical since treatment regimens, educational approaches, and dietary counsel will differ markedly
between the two diagnoses.
Type 2 diabetes has a significant prevalence of comorbidities already present at the
time of diagnosis (338). It is recommended
that blood pressure measurement, a fasting
lipid profile, microalbuminuria assessment,
and dilated eye examination be performed
at the time of diagnosis. Thereafter, screening guidelines and treatment recommendations for hypertension, dyslipidemia,
microalbuminuria, and retinopathy in
youth with type 2 diabetes are similar to
those for youth with type 1 diabetes. Additional problems that may need to be addressed include polycystic ovary disease
and the various comorbidities associated
with pediatric obesity such as sleep apnea, hepatic steatosis, orthopedic complications, and psychosocial concerns. The
ADA consensus statement on this subject
(23) provides guidance on the prevention, screening, and treatment of type 2
diabetes and its comorbidities in young
people.
care.diabetesjournals.org
S41
C. Older adults
Recommendations
Older adults who are functional, cognitively intact, and have significant life
expectancy should receive diabetes care
using goals developed for younger
adults. (E)
Glycemic goals for older adults not
meeting the above criteria may be relaxed using individual criteria, but hyperglycemia leading to symptoms or
risk of acute hyperglycemic complications should be avoided in all patients.
(E)
Other cardiovascular risk factors
should be treated in older adults with
consideration of the time frame of benefit and the individual patient. Treatment of hypertension is indicated in
virtually all older adults, and lipid and
aspirin therapy may benefit those with
life expectancy at least equal to the time
frame of primary or secondary prevention trials. (E)
Screening for diabetes complications
should be individualized in older
adults, but particular attention should
be paid to complications that would
lead to functional impairment. (E)
Position Statement
Heart Association class III and class IV)
and if used at all should be used very cautiously in those with, or at risk for, milder
degrees of CHF. Sulfonylureas, other insulin secretagogues, and insulin can cause
hypoglycemia. Insulin use requires that
patients or caregivers have good visual
and motor skills and cognitive ability.
Drugs should be started at the lowest dose
and titrated up gradually until targets are
reached or side effects develop.
Screening for diabetes complications
in older adults also should be individualized. Particular attention should be paid
to complications that can develop over
short periods of time and/or that would
significantly impair functional status,
such as visual and lower-extremity complications.
D. Cystic fibrosisrelated diabetes
Cystic fibrosisrelated diabetes (CFRD) is
the most common comorbidity in persons
with CF, occurring in about 20% of adolescents and 40 50% of adults. The additional diagnosis of diabetes in this
population is associated with worse nutritional status, more-severe inflammatory
lung disease, and greater mortality from
respiratory failure. For reasons that are
not well understood, women with CFRD
are particularly vulnerable to excess morbidity and mortality. Insulin insufficiency
related to partial fibrotic destruction of
the islet mass is the primary defect in
CFRD. Genetically determined function
of the remaining -cells and insulin resistance associated with infection and inflammation may also play a role.
Encouraging new data suggest that early
detection and aggressive insulin therapy
have narrowed the gap in mortality between CF patients with and without diabetes, and have eliminated the sex
difference in mortality.
A consensus conference on CFRD
was co-sponsored in 2009 by the American Diabetes Association, the Cystic Fibrosis Foundation, and the Pediatric
Endocrine Society. Recommendations for
the clinical management of CFRD can be
found in an ADA position statement
(344a).
VIII. DIABETES CARE IN SPECIFIC
SETTINGS
A. Diabetes care in the hospital
Recommendations
All patients with diabetes admitted to
the hospital should have their diabetes
care.diabetesjournals.org
Hyperglycemia in the hospital is extensively reviewed in an ADA technical review (345). A recent updated consensus
statement by the American Association of
Clinical Endocrinologists (AACE) and the
ADA (346) forms the basis for the discussion and guidelines in this section.
The literature on hospitalized patients with hyperglycemia typically describes three categories:
1. Medical history of diabetes: diabetes
has been previously diagnosed and acknowledged by the patients treating
physician.
2. Unrecognized diabetes: hyperglycemia
(fasting blood glucose 126 mg/dl or
random blood glucose 200 mg/dl)
occurring during hospitalization and
confirmed as diabetes after hospitalization by standard diagnostic criteria but
unrecognized as diabetes by the treating physician during hospitalization.
3. Hospital-related hyperglycemia: hyperglycemia (fasting blood glucose
126 mg/dl or random blood glucose
200 mg/dl) occurring during the
hospitalization that reverts to normal
after hospital discharge.
The management of hyperglycemia in the
hospital has often been considered secondary in importance to the condition
that prompted admission (345). However, a body of literature now supports
targeted glucose control in the hospital
setting for potential improved clinical
outcomes. Hyperglycemia in the hospital
may result from stress, decompensation
of type 1 or type 2 or other forms of diabetes, and/or may be iatrogenic due to
withholding of anti-hyperglycemic medi-
S43
Position Statement
stable may be maintained with a glucose
range below the above cut points. Conversely, higher glucose ranges may be acceptable in terminally ill patients or in
patients with severe comorbidities, as
well as in those in patient-care settings
where frequent glucose monitoring or
close nursing supervision is not feasible.
Clinical judgment, combined with
ongoing assessment of the patients clinical status, including changes in the trajectory of glucose measures, the severity of
illness, nutritional status, or concurrent
use of medications that might affect glucose levels (e.g., steroids, octreotide)
must be incorporated into the day-to-day
decisions regarding insulin dosing (346).
2. Anti-hyperglycemic agents in
hospitalized patients
In the hospital setting, insulin therapy is
the preferred method of glycemic control
in majority of clinical situations (346). In
the ICU, intravenous infusion is the preferred route of insulin administration.
When the patient is transitioned off intravenous insulin to subcutaneous therapy,
precautions should be taken to prevent
hyperglycemia escape (360,361). Outside
of critical care units, scheduled subcutaneous insulin which delivers basal, nutritional, and correction (supplemental)
components is preferred. Prolonged therapy with sliding scale insulin (SSI) as the
sole regimen is ineffective in the majority
of patients, increases risk of both hypoglycemia and hyperglycemia, and has recently been shown to be associated with
adverse outcomes in general surgery patients with type 2 diabetes (362). SSI is
potentially dangerous in type 1 diabetes
(346). The reader is referred to several
recent publications and reviews that describe currently available insulin preparations and protocols and provide guidance
in use of insulin therapy in specific clinical settings including parenteral nutrition
(363), enteral tube feedings, and with
high-dose glucocorticoid therapy (346).
There are no data on the safety and
efficacy of oral agents and injectable noninsulin therapies such as GLP1 analogs
and pramlintide in the hospital. They are
generally considered to have a limited role
in the management of hyperglycemia in
conjunction with acute illness. Continuation of these agents may be appropriate in
selected stable patients who are expected
to consume meals at regular intervals and
they may be initiated or resumed in anticipation of discharge once the patient is
clinically stable. Specific caution is recare.diabetesjournals.org
quired with metformin, due to the possibility that a contraindication may develop
during the hospitalization, such as renal
insufficiency, unstable hemodynamic status, or need for an imaging study that requires a radio-contrast dye.
3. Preventing hypoglycemia
Hypoglycemia, especially in insulintreated patients, is the leading limiting
factor in the glycemic management of
type 1 and type 2 diabetes (173). In the
hospital, multiple additional risk factors
for hypoglycemia are present. Patients
with or without diabetes may experience
hypoglycemia in the hospital in association with altered nutritional state, heart
failure, renal or liver disease, malignancy,
infection, or sepsis. Additional triggering
events leading to iatrogenic hypoglycemia
include sudden reduction of corticosteroid dose, altered ability of the patient to
report symptoms, reduction of oral intake, emesis, new NPO status, inappropriate timing of short- or rapid-acting
insulin in relation to meals, reduction of
rate of administration of intravenous dextrose, and unexpected interruption of enteral feedings or parenteral nutrition.
Despite the preventable nature of
many inpatient episodes of hypoglycemia, institutions are more likely to have
nursing protocols for the treatment of hypoglycemia than for its prevention.
Tracking such episodes and analyzing
their causes are important quality improvement activities (346).
S45
blood, terms that are often used interchangeably and can lead to misinterpretation. Most commercially available
capillary blood glucose meters introduce
a correction factor of 1.12 to report a
plasma adjusted value (374).
Significant discrepancies between
capillary, venous, and arterial plasma
samples have been observed in patients
with low or high hemoglobin concentrations, hypoperfusion, and the presence of
interfering substances particularly maltose, as contained in immunoglobulins
(375). Analytical variability has been described with several POC meters (376).
Increasingly, newer generation POC
blood glucose meters correct for variation
in hematocrit and for interfering substances. Any glucose result that does not
correlate with the patients status should
be confirmed through conventional laboratory sampling of plasma glucose. The
FDA has become increasingly concerned
about the use of POC blood glucose
meters in the hospital and is presently reviewing matters related to their use.
9. Discharge planning
Transition from the acute care setting is a
high-risk time for all patients, not just
those with diabetes or new hyperglycemia. Although there is an extensive literature concerning safe transition within
and from the hospital, little of it is specific
to diabetes (377). It is important to remember that diabetes discharge planning
is not a separate entity, but part of an
overall discharge plan. As such, discharge
planning begins at admission to the hospital and is updated as projected patient
needs change.
Inpatients may be discharged to varied settings, including home (with or
without visiting nurse services), assisted
living, rehabilitation, or skilled nursing
facilities. The latter two sites are generally
staffed by health professionals; therefore
diabetes discharge planning will be limited to communication of medication and
diet orders. For the patient who is discharged to assisted living or to home, the
optimal program will need to consider the
type and severity of diabetes, the effects of
the patients illness on blood glucose levels, and the capacities and desires of the
patient. Smooth transition to outpatient
care should be ensured. The Agency for
Healthcare Research and Quality recommends that at a minimum, discharge
plans include:
Medication reconciliation: The patients medications must be crosschecked to ensure that no chronic
medications were stopped and to ensure the safety of new prescriptions.
Whenever possible, prescriptions for
new or changed medication should be
filled and reviewed with the patient and
family at or before discharge
Structured discharge communication:
Information on medication changes,
pending tests and studies, and follow-up needs must be accurately and
promptly communicated to outpatient
physicians, as soon as possible after discharge.
Position Statement
in the last 10 years, both in primary care
settings and in endocrinology practices.
Mean A1C nationally has declined from
7.82% in 1999 2000 to 7.18% in 2004
based on National Health and Nutrition
Examination Survey (NHANES) data
(379). This has been accompanied by improvements in lipids and blood pressure
control and led to substantial reductions
in end-stage microvascular complications
in those with diabetes (380). Nevertheless, in some studies only 57.1% of adults
with diagnosed diabetes achieved an A1C
of 7%, only 45.5% had a blood pressure
130/80 mmHg, and just 46.5% had a
total cholesterol 200 mg/dl, with only
12.2% of people with diabetes achieving
all three treatment goals (381). Moreover,
there is persistent variation in quality of
diabetes care across providers and across
practice settings even after adjusting for
patient factors that indicates the potential
for substantial further improvements in
diabetes care.
While numerous interventions to improve adherence to the recommended
standards have been implemented, a major contributor to suboptimal care is a delivery system that too often is fragmented,
lacks clinical information capabilities, often duplicates services, and is poorly designed for the delivery of chronic care.
The Chronic Care Model (CCM) includes
six core elements for the provision of optimal care of patients with chronic disease: 1) delivery system design (moving
from a reactive to a proactive care delivery
system, where planned visits are coordinated through a team-based approach; 2)
self-management support; 3) decision
support (basing care on consistent, effective care guidelines); 4) clinical information systems (using registries that can
provide patient-specific and populationbased support to the care team); 5)
community resources and policies (identifying or developing resources to support
healthy lifestyles); and 6) health systems
(to create a quality-oriented culture). Alterations in reimbursement that reward
the provision of quality care, as defined by
the attainment of evidence-based quality
measures, will also be required to achieve
desired outcome goals. Redefinition of the
roles of the clinic staff and promoting selfmanagement on the part of the patient are
fundamental to the successful implementation of the CCM (382). Collaborative,
multidisciplinary teams are best suited to
provide such care for people with chronic
conditions like diabetes and to facilitate
care.diabetesjournals.org
Objective 3
Change the system of care: Research on
the comprehensive CCM suggests additional strategies to improve diabetes care,
including the following:
Objective 2
Patient behavior change: Implement a
systematic approach to support patients
behavior change efforts as needed including 1) healthy lifestyle (physical activity,
healthy eating, nonuse of tobacco, weight
management, effective coping, medication taking and management); 2) prevention of diabetes complications (screening
for eye, foot, and renal complications; immunizations); and 3) achievement of appropriate blood pressure, lipid, and
glucose goals.
The most successful practices have an institutional priority for quality of care, expanding the role of teams and staff,
redesigning their delivery system, activating and educating their patients, and using electronic health record tools
(393,394). Recent initiatives such as the
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